Machine Operator
US - Indiana - Indianapolis Update time: September 16,2020
Job Description
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Reviews batch paperwork and follows supervisor instructions to understand and perform the necessary packaging procedures required for assembly of each study.
- Cleans packaging rooms and machinery in accordance to Standard Operating Procedures and Good Manufacturing Principles.
- Performs manual and automated filling and packaging of blistered and bottled pharmaceutical products independently and approves in-process products at other stations.
- Performs and ensures proper card and drug placement using various secondary card sealing machinery.
- Accepts or rejects in-process clinical supplies according to acceptability standards determined by Good Manufacturing Principles, customer requirements, and Standard Operating Procedures.
- Labels and assembles both blinded (following a randomization schedule) and open clinical supplies in conjunction with other FCS personnel ensuring proper label placement and proper documentation of labeling activities.
- Accurately counts out and prepares packaging supplies to ensure proper accountabilities prior to and at the completion of a job order. Assists Quality Assurance personnel, Production Supervisors and Line Leaders in staging and reconciliation of components as required.
- Performs final check of work in-process and finished products and then packs these goods into appropriately labeled containers.
- Starts, stops, and operates packaging machinery that blisters, fills, wraps, labels, or packs pharmaceutical products.
- Observes machinery to detect malfunctions and ensure the safe and effective operation of packaging machinery in accordance with our SOP’s, GMP’s, and customer specified instructions.
- Performs several in-process adjustments to the machines that include but are not limited to: roll changes, pen changes, Teflon changes, various simple machine adjustments, assembly and disassembly of various machinery, reloading of components into auto-fed machinery, blow-outs, simple alignment functions, resetting of pre-programmed electronic counters, and the signing of machine logs for the cleaning and/or set-up of on-going jobs.
- Conducts all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
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